Surgical bone drill

The present application claims the benefit of U.S. Provisional Patent Application No. 63/481,071, filed Jan. 23, 2023, which is incorporated herein by reference in its entirety.

The present disclosure relates to a surgical bone drill and, more particularly, relates to surgical bone drills for use in drilling bones that have soft tissue beyond the bone being drilled.

The human skeleton consists of many kinds of bones including, upper and lower jawbones and spine or skull, that can have, for example, various thicknesses and surrounding materials. In many surgical treatments or therapies, it is desired to provide one or plural holes into a bone of a patient. Depending on the location, thickness, and surrounding materials such as membrane linings and other soft tissues, drilling the bone can present various challenges.

Many tools such as drills are used for various drill procedures. Conventional drill bits can be applied where there is sufficient bone depth or in locations where other important anatomy such as membranes, nerves or cells are not present. However, in cases where the bone density is light, bone thickness is thin, or other important parts such as the membranes, nerves or cells are present, it is required to drill such that no damage is done to these other important parts. This presents challenges to even the most skillful users of the drill. While conventional drill bits may easily penetrate the bone, the tips of the drill blades can damage the membrane by tearing or rolling when the tip of the drill contacts the membrane. Furthermore, previous approaches have utilized a drill bit that needed a pilot drill or bur to initiate the cut in the bone.

For example, in many surgical operations it is necessary to obtain direct access to the cranial cavity and the brain underneath the skull bone. To perform such operations, it is often necessary to drill holes through the skull bone. Since the bone is very hard, it is necessary to apply significant pressure to drill through the bone, but it is also necessary to stop the drill once the bone has been penetrated to prevent damage to the soft tissue underneath.

The present disclosure relates to systems, methods, and devices for drilling into bone of a patient.

According to the present disclosure, in certain scenarios, a surgical bone drill may include a housing and a drill bit. The drill bit may include a bit proximal portion that is mounted within the housing, and a bit distal portion that extends distally from the housing and includes a cutting tip configured to drill into bone of a patient. The surgical bone drill may also include a depth limiter having a distal end positioned adjacent the bit distal portion. A location of the depth limiter is adjustable with respect to the housing to select an exposed length of the bit distal portion that is exposed beyond the depth limiter. The depth limiter thereby limits a depth that the drill bit is able to drill into the bone. The surgical bone drill additionally may include a drive mechanism disposed within the housing and operably connected with the bit proximal portion of the drill bit to rotate the drill bit to cause the drill to drill into the bone.

In certain implementations, the surgical bone drill may further include a locking nut configured to prevent rotation of the depth limiter after the exposed length of the bit distal portion is selected. In certain implementations, the depth limiter is affixable relative to the housing.

In various implementations, the housing of the surgical drill may include a sleeve configured to receive the bit proximal portion. In such implementations, the depth limiter may include an adjustment collar that is adjustably threaded onto the sleeve to enable adjustment of the exposed length. Optionally, the adjustment collar may include a limiter distal portion having a first height and a first width and positioned adjacent the bit distal portion, and a limiter proximal portion having a second height and a second width. The limiter distal portion is configured to abut the patient. The first height and the first width of the bit distal portion are less than the second height and the second width of the limiter proximal portion.

In some examples, the cutting tip of the drill bit may be a convex conical cutting tip with a spike extending distally from the cutting tip, the spike being sufficiently sharp to pierce a dura of the patient.

According to another scenario, the present disclosure relates to a surgical bone drill that may include a housing, a drill bit including a cutting tip configured to drill into bone of a patient, and a depth limiter mounted to the housing. The depth limiter may be configured to select an exposed length of drill bit that is exposed beyond the depth limiter which thereby limits a depth that the drill bit drills into the bone. The depth limiter may include a limiter distal portion having a first width and a first height, and being positioned adjacent the exposed length of drill bit, and a limiter proximal portion having a second width and a second height. The first width and the first height of the limiter distal portion is smaller than the second width and the second height of the limiter proximal portion. The surgical drill may also include a drive mechanism operably connected with a proximal portion of the drill bit to rotate the drill bit to cause the drill to drill into the bone without rotation of the depth limiter.

Optionally, the depth limiter may taper between the limiter proximal portion and the limiter distal portion. Additionally, and/or alternatively, the limiter proximal portion may terminate distally at a limiter distal end which is smooth and configured to abut the patient.

In certain implementations, the limiter proximal portion may be adjustable with respect to the housing to select the exposed length of drill bit that is exposed beyond the depth limiter and the limiter distal portion is adjacent to the exposed length of drill bit.

In certain implementations, the housing of the surgical drill may include a sleeve configured to receive the bit proximal portion. Additionally, the depth limiter may include an adjustment collar that is adjustably threaded onto the sleeve to enable adjustment of the exposed length.

In various implementations, the drill bit may include a bit distal portion which includes a convex conical cutting tip with a spike extending distally from the cutting tip. The spike is sufficiently sharp to pierce a dura of the patient.

The surgical bone drill can further include a locking nut configured to prevent rotation of the depth limiter after the exposed length of the bit distal portion is selected.

In some examples, the drill bit includes a bit proximal portion that is mounted within the housing, and a bit distal portion that extends distally from the housing. In some cases, the depth limiter surrounds the bit distal portion.

The present disclosure additionally discloses scenarios that relate to a cranial drill bit. The cranial drill bit may include an elongated body. The elongated body includes a bit distal portion which has a cutting tip configured to drill into bone of a patient, a cutting flute that extends proximally from the cutting tip. The cutting flute may be configured to remove material as the cutting tip drills into the bone of the patient. Additionally, the cranial drill bit may include a spike extending distally from the cutting tip and terminating at a point, wherein the spike is configured to cut a dura of the patient, and the spike is smaller than the cutting tip.

In certain implementations, the spike of the cranial drill bit may include the cutting flute.

In certain implementations, the cranial drill bit may be included in any of the surgical drills as discussed above.

Additionally, the present disclosure discloses scenarios relating to a surgical kit. The surgical kit may include any of the surgical bone drills discussed herein and other components such as one or more devices for evacuation of fluid from a subdural space of the patient.

For example, the one or more devices for evacuation of fluid from the subdural space may include: a subdural evacuation port device, and a negative pressure device.

In some cases, the kit may also include a tapper for creating threads within a hole created by the drill.

The subdural space of the human head is the space located between the brain and the lining of the brain, which is referred to as the dura mater (hereinafter referred to as the “dura”). Hemorrhages on the surface of the brain, for example, may cause a condition known as a subdural hematoma. The subdural hemorrhages may have a number of causes. For example, elderly persons may be more susceptible to subdural hemorrhages because as the brain ages it tends to become atrophic and the subdural space between the brain and the dura gradually enlarges. Bridging veins between brain and dura frequently stretch and rupture as a consequence of relatively minor head injuries, thus giving rise to a collection of blood in the subdural space. Further, severe linear acceleration or deceleration of the brain can result in the brain moving excessively with respect to the dura, often causing rupture of the bridging veins or the blood vessels on the surface of the brain, which can cause subdural hemorrhages in an otherwise healthy brain. Since the subdural hematomas primarily comprise collections of liquid, the treatment may range from the performance of a craniotomy to the use of a burr hole (depending upon severity), that each require creating hole(s) in the skull (e.g., using a drill). An example of a process for evacuating subdural space after the subdural space has been accessed is described in U.S. Pat. No. 7,694,821.

For example, for creating hole(s) in the skull to access the subdural space of a human brain, a drill drills a hole into a patient's skull. Once the hole is drilled, the dura of the brain is punctured to allow access to the subdural space. However, existing drills use a relatively dull drill bit which can push on the dura and can lead to complications. Moreover, multiple instruments may be required after the drill has drilled the hole to puncture the dura (e.g., a needle, stylet, or other device can be used to puncture the dura) adding additional complexity. Finally, to achieve a precise depth that the drill bit drills into the patient's skull a depth limiter and/or drill stop is used for the precise depth (drill stop and depth limiter are used interchangeably herein). Such a depth limiter is attached to the drill bit and rotates with the drill bit requiring an incision large enough for the depth limiter and drill bit to be made in a human scalp prior to boring the hole into the skull creating a larger hole than is needed for the surgical treatment itself.

The present disclosure relates to systems that facilitate precisely drilling bones and penetrating other desired tissue without damaging surrounding tissue, such as soft tissue opposing the bone being drilled. Examples can include, but are not limited to, the skull, spine, the maxillary sinus area, and other bones adjacent to soft tissue. For example, the systems of the current disclosure can be used for accessing the subdural region of a subject and more particularly pertains to a surgical bone drill which can be used for accessing the subdural region of a subject in a manner that is minimally invasive. The surgical bone drill of the current disclosure can be used without the use of a pilot drill while protecting the soft tissue opposing the bone being drilled.

1 3 FIGS.- 100 100 102 104 106 108 108 102 106 102 108 106 depict a surgical bone drillin accordance with the principles of the present disclosure. The surgical bone drillincludes a housing, a drive mechanism, a depth limiter, and a drill bit. The drill bitis rotatably mounted within the housingand the depth limiteris affixed directly to the housingto allow the drill bitto rotate without causing rotation of the depth limiter.

100 100 108 108 100 The term “drill bit” as used herein can relate to a longitudinal rotatable piece adapted to be mounted to a drilling device (e.g., surgical bone drill) and rotated by a drive mechanism of the surgical bone drill. The drill bithas a rod like or cylindrical form wherein the circumference is profiled in a particular manner allowing for the drill bit to drill into bone. Alternatively, the drill bitmay have a different profile that allows for rotation and drilling, such as having a square, rectangular, prismatic, or other suitable cross-sectional shape. The drill bit is made of a hard material suitable for cutting or otherwise drilling into bone or the material that is being drilled through allowing the surgical bone drillto create holes. In some examples, the drill is formed from a metal, e.g., surgical steel or other stainless steels, high-speed steel, or tungsten carbide, or a ceramic. The drill bit might be coated with a suitable material to aid chip evacuation, to provide a hard exterior surface, or for other purposes. Such coating material can include, for example, diamond-like carbon (DLC), titanium nitride (TiN) or other materials and or layers.

1 3 FIGS.- 108 122 120 108 120 122 108 124 122 108 126 120 126 108 130 120 130 123 126 108 122 a Referring to, an embodiment of a drill bithas an elongated, longitudinal body extending along an axis and having a proximal endand a distal end, such that the body of the drill bitextends between the distal endand the proximal end. The drill bitincludes a bit proximal portionextending from a flute(s) towards the proximal end. In this embodiment, the bit proximal portion has a smooth exterior profile which allows for the bit proximal portion to rotate smoothly within the housing, although other bits can have different exterior profiles and be sized to rotate within the housing. The flutes in this embodiment are spiral flutes. Other embodiments can have a longitudinal flute(s) that is parallel to the longitudinal axis, or other configurations suitable for cutting in a drilling operation. The drill bitadditionally includes a bit distal portiontowards the distal end. The bit distal portionof the drill bitincludes a cutting portionformed at the distal endof the body that includes a main cutting faceextending from a cutting tip. In some examples, the bit distal portionof the drill bitalso includes spiral flute(s) formed around the body and extending from the main cutting face along the axis of the body and towards the proximal end(discussed below in more detail).

124 102 126 102 124 104 124 127 124 104 127 128 128 128 108 128 108 124 104 124 104 128 108 128 108 128 128 The bit proximal portionextends into and is rotatably anchored within the housingwhile the bit distal portionextends out of the housing. Specifically, the bit proximal portionis configured to operably connect with the drive mechanism, via one or more linkages (discussed below). In certain examples, the bit proximal portionincludes a connection interfacewhich operably connects the bit proximal portionto the drive mechanism. In certain examples, the connection interfaceis configured to be connected to or interface with a rotational coupling. In certain examples, the rotational couplingis a bit gear. In certain examples, the bit gear is a pinion. Other types of gears are additionally possible such as a worm gear, a screw gear, a bevel gear or a different suitable gear. Other rotational couplings are within the scope of this disclosure such as, without limitation, a threaded coupling, a belt interface, or a different suitable rotational coupling. In certain examples, the rotational couplinginterface is separate from the drill bit, however, it will be appreciated that the rotational couplinginterface can be integrally formed with the drill bit. It will also be appreciated that the bit proximal portioncan engage with the drive mechanismin other ways, for example, the bit proximal portioncan engage with a belt or a different suitable engagement interface if, for example, the drive mechanismincluded a belt. In some examples, the rotational couplingand the drill bitare formed from different materials. In other examples, the rotational couplingand the drill bit are unitary or formed from a similar material. In some examples, the drill bitis formed from a metallic material and the rotational couplingis formed from a polymer. In some examples, the rotational couplingis formed from acrylonitrile butadiene styrene (hereinafter: ABS); Polycarbonate; Polypropylene; Nylon; or other suitable materials.

126 108 130 130 108 130 130 123 121 120 123 123 121 104 100 121 121 121 121 121 121 108 208 121 108 108 121 108 108 The bit distal portionof the drill bitincludes a cutting portion. The cutting portionincludes a flute. Flutes are sharp slots that corkscrew upwards along the length and are responsible for cutting and ejecting bone chips as the drill bitrotates. In certain examples, the cutting portionincludes two flutes. More or less flutes are additionally possible. The cutting portionincludes a cutting tipthat terminates at a spikeat the distal end. In some embodiments, the cutting tiphas an angle of about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees or any other suitable angle from opposite surfaces of the cutting tip. In some examples, the cutting tip has an angle of about 5-40 degrees, about 10-35 degrees, about 15-30 degrees, about 20-25 degrees, 25-30 degrees, or any other suitable range. The cutting tipin combination with the spikeare configured to initiate drilling into bone of a patient by application of pressure without engagement of the drive mechanism, thereby allowing the surgical bone drillto grip the bone and preventing slippage (without the use of additional tools such as a pilot drill). In certain embodiments, the spikeadditionally limits slippage and grips the bone. In certain examples, the spikeis additionally configured to pierce the dura of a patient (discussed below). In some examples, the spikeis shaped conically and forms a tip angle of about 5 degrees, about 10 degrees, about 13 degrees, about 15 degrees, about 20 degrees, as measured from opposite surfaces of the spike. In other examples, the tip angle has a range of about 5-20 degrees, about 7-18 degrees, about 9-16 degrees, about 11-14 degrees, or any other suitable range. In other embodiments, the spikeis spear shaped. The spikeis sufficiently sharp to cut into the bone as the drill bitis rotated and sharp enough to puncture tissue such as the dura. In some embodiments, the spikeis integrally formed with the drill bitsuch that the drill bittapers into the spikeat a fine point. In some examples, the maximum diameter of the drill bitis about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm or any other suitable maximum diameter. In some examples, the maximum diameter of the drill bitis between about 5 mm-7 mm, about 5.3 mm-6.7 mm, about 5.5 mm-6.5 mm, about 5.7 mm-6.3 mm, about 5.9 mm-6.1 mm, or any other suitable range of maximum diameters.

2 FIG. 5 FIG. 104 100 124 108 104 104 108 104 108 Referring to, the drive mechanismof the surgical bone drillis operably connected to or interfaces with the bit proximal portion, and is configured to rotate the drill bit. The drive mechanismis configured to be manually driven (e.g., an operator causes the drive mechanismto rotate the drill bitby rotation of a handle, crank, a similar manual rotator, via one or more linking mechanisms) or motor operated (e.g., as shown in, in which a motor causes the drive mechanismto rotate the drill bit).

2 FIG. 2 FIG. 104 140 142 108 128 108 142 142 128 124 140 108 142 128 140 144 140 104 104 104 In, the drive mechanismis a manually driven drive mechanism and includes a crankattached to a rotational couplingthat interfaces with the drill bitvia the rotational couplingof the drill bit. Types of rotational couplingcan include, without limitation, a gear, a belt, or a similar suitable rotational coupling. For example, the rotational couplingcan be a rack type gear including a plurality of teeth that are configured to engage with teeth included in the rotational couplingof the bit proximal portionsuch that rotation of the crankcauses rotation of the drill bit. Whileillustrates the rotational couplinghaving a rotational axis that is perpendicular to that of the rotational coupling, the disclosure is not so limiting, and other interface angles are within the scope of this disclosure. Optionally, the crankincludes an outer gripwhich reduces hand slippage while a user is rotating the crank. The drive mechanismcan be formed from any suitable material. In some examples, the drive mechanismis formed from a polymer. In some examples, the drive mechanismis formed from ABS, Nylon, Polypropylene, or any other suitable material.

In embodiments including an electric motor the motor can be powered using a suitable power source, such as a battery, a power cable, an AC power source, a DC power source, a docking station, or any other suitable power source. In certain examples, the power source can be a rechargeable battery, a disposable battery or may be a single use battery. It will be appreciated that the motor may be powered by any other suitable mechanism that generates sufficient torque for the drill to create a hole. Other embodiments can use pneumatic motors or motors powered by other suitable types of sources.

102 100 124 104 104 124 102 102 102 102 2 FIG. The housingof the surgical bone drillis configured to contain the bit proximal portionand the drive mechanismsuch that the drive mechanismis operably connected to the bit proximal portion. In certain examples, the housingis a multi-piece housing. Alternatively, the housingcan be configured as a single piece housing. In the example of, the housingincludes three pieces, however the housingcan be a molded single piece housing, a two-piece housing (e.g., a clamshell housing), or a housing having more than three pieces.

102 152 154 156 152 154 158 152 154 158 152 154 156 160 162 162 152 154 160 124 162 102 126 162 156 152 154 102 156 152 156 154 162 154 154 a The housingincludes a first housing portion, a second housing portion, and a sleeve. The first housing portionand the second housing portioninclude connectorsfor attaching the first housing portionto the second housing portion. In certain examples, the connectorsare snap fit connectors. In other examples, the first and second housing portions,can connect via fasteners or other suitable attachment mechanism. The sleeveincludes a sleeve distal portionand a sleeve proximal portion. The sleeve proximal portionis received within the first and second housing portions,and the sleeve distal portionreceives the bit proximal portionwhich extends at least partially into the sleeve proximal portioninto the housing. The bit distal portionextends distally out of the sleeve. The sleeve proximal portionincludes a connection interface which allows the sleevelock between the first and the second housing portions,. It will be appreciated that if the housingwas, for example, a two-piece housing a portion (e.g., half) of the sleevecould be configured to be received within or interface with the first housing portionand a portion (e.g., half) of the sleevecould be configured to be received within or interface with the second housing portion. In certain embodiments, the sleeve proximal portionis received within a slotof the second housing portion. In some examples, the housing is made from a polymer. In some examples the housing is made from ABS Polycarbonate; Polypropylene; Nylon; or other suitable materials.

152 152 152 104 152 140 152 140 142 108 142 102 154 154 154 104 104 102 124 108 a a a b b The first housing portionincludes an opening. The openingis sized such that at least a portion of the drive mechanismcan fit within the opening, with the crankextending out of the first housing portionallowing for an operator to rotate the crankthereby rotating the rotational couplingand the drill bit. The rotational couplingextends within the housing. The second housing portionincludes a circular portion. The circular portioncan receive at least a portion of the drive mechanismand allow the drive mechanismto rotate within the housingand engage the bit proximal portion(via the rotational coupling(s)) to rotate the drill bit. In certain examples, the gear includes a reciprocal opening that can extend around the circular opening thereby allowing for rotation.

156 124 124 156 152 154 124 154 122 108 154 154 154 142 104 128 108 104 108 104 102 104 102 c c As discussed above, the sleeveis configured to receive the bit proximal portion. The bit proximal portionextends through the sleeveand between the first and second housing portions,. In certain examples, the bit proximal portionextends into only the second housing portion. The proximal endof the drill bitextends into a slotin the second housing portion. The slotis configured to allow the rotational couplingof the drive mechanismto engage with the rotational couplingof the drill bitsuch that when the drive mechanismrotates, the drill bitrotates. It will be appreciated that although only a portion of the drive mechanismis shown extending into the housing, in other examples the entire drive mechanismcan be configured to fit within the housing.

100 106 126 102 126 206 126 206 In various embodiments, the surgical drillalso includes a depth limiterconfigured to selectively control a length of the bit distal portionthat is exposed or extends from the housingthereby limiting the depth that the bit distal portionextends into the skullof a patient. In some examples, the depth required for the procedure that the bit distal portionextends into the skullis determined by magnetic resonance imaging (MRI), computerized tomography scan (CT scan), or X-ray or a different method of generating images within the body of a patient.

106 102 106 156 102 106 102 106 102 106 156 102 106 102 126 106 108 106 206 160 106 106 156 106 156 106 160 108 206 106 156 126 106 156 106 108 106 106 106 In certain embodiments, the depth limiteris mounted directly to the housing(as depicted, the depth limiteris mounted to the sleeveof the housing). In certain examples, the depth limiteris affixable relative to the housing. In certain examples, the depth limiteris affixable and adjustable relative to the housing. In certain examples, the depth limiteris affixed to the sleeveof the housing. The depth limitercan be affixed to the housingin any applicable manner that allows for selection of length of the exposed bit distal portion, without causing rotation of the depth limiterwhen the drill bitis rotated at least until the depth limitercontacts or abuts the surface (the skull) which the depth is limited through. For example, the sleeve distal portionincludes threads and the depth limiterincludes reciprocal threading that allows for the depth limiterto be mounted to the sleeveat a desired location. In some embodiments, the location of the mounted depth limitercan be changed up or down the sleeveby rotation of the depth limiterover the threads of the sleeve distal portion. Based on the depth selected for insertion of the drill bitwithin the skull(e.g., from the MRI or X-ray above), the depth limitercan be adjusted to a desired position over the sleeve, which in turn exposes a desired length of the bit distal portionthat allows drilling to the selected depth only. In other examples, the depth limitercan be affixed to the housing sleeveby a ratchet or other suitable mechanisms. It will be appreciated that the depth limiterbeing threaded allows for easier access to adjusting the exposed length of the drill bitas compared to, for example, a set screw. The depth limitercan be formed from a suitable material. In some examples, the depth limiteris formed from a polymer. In some examples, the depth limiteris formed from ABS.

106 170 108 170 170 170 170 170 102 100 170 106 170 170 170 170 156 170 102 170 170 170 a b a a a a a d a c a The depth limiter, in certain examples, may also include an adjustment collarfor adjusting the length which the drill bitis exposed. The adjustment collarincludes a limiter proximal portionand a limiter distal portion. The limiter proximal portionhas a width and a length. The width of the limiter proximal portionis sufficient to attach to the housingof the surgical bone drilland the length of the limiter proximal portionis sufficient to allow a user to easily grasp the depth limiterat least at the limiter proximal portion. In certain embodiments, the limiter proximal portionincludes internal threadsallowing the adjustment collarto attach to the threading of the sleeveportion. In other examples, the adjustment collaris affixable to the housingvia ratcheting or a similar method. The limiter proximal portionadditionally includes an external gripallowing for the limiter proximal portionto be easily rotated.

170 170 170 170 170 156 170 126 170 120 108 120 100 108 170 102 126 126 126 170 126 108 170 126 108 126 516 102 170 156 b b a b b 5 FIG. The limiter distal portionalso includes a width and a length. In some embodiments, the width, and the length of the limiter distal portionis less than the width and the length of the limiter proximal portion. In certain embodiments, the width, and the length of the limiter distal portionare small enough so that the adjustment collarcannot rotate completely onto the sleeve. In this way, at least the limiter distal portioncovers the bit distal portion. In some examples, when the adjustment collaris rotated distally to the bit distal end, the drill bitis completely covered. Completely covering the bit distal endallows for the surgical bone drillto easily be stored and transported without risking damage to the drill bit. In some examples, when the adjustment collaris rotated proximally towards the housingas far as possible, the maximum length of the bit distal portionis exposed. In some examples, the maximum length the bit distal portionis exposed is about 3.5 cm, about 4 cm, about 4.5 cm, about 5 cm or other suitable maximum length. In some examples, the maximum length the bit distal portionis exposed is between about 3.5 cm-0.5 cm, about 3.8 cm-4.7 cm, about 4.1-4.4 cm, or other suitable range. In some examples, the adjustment collarsurrounds the bit distal portionof the drill bitthat is not exposed, in other examples the adjustment collarsurrounds a portion of the bit distal portionthat is not exposed. In some embodiments, the drill bitincludes permanent markings which show the length exposed of the distal portion. The markings can be formed by etching, engraving, laser marking, color marking, or other suitable marking method that does not change the shape of the drill bit.depicts a drill bit having markingsdepicting various depths. The markings may represent commonly used depths. In other embodiments, markings are on the housing, adjustment collar, the sleeveor other suitable location. For example, the markings could be exposed as the depth limiter is rotated showing a user the exposed depth.

170 170 170 170 170 200 170 170 170 170 170 170 170 202 170 206 170 170 170 170 170 170 200 170 108 170 170 b a b a b b b f b a b f b b a f b a b b b b 3 FIG. In certain embodiments, the limiter distal portionis positioned at an angle X relative to the limiter proximal portion(see) to allow for the limiter distal portionto be smaller than the limiter proximal portion. The limiter distal portionis relatively smooth and is configured to abut the craniumof a patient (discussed in further detail below). The limiter distal portioncan additionally assist in spreading the tissue of an incision made in a patient and directly abuts the bone being drilled into. In certain embodiments, the limiter distal portiontapers at approximately angle X as at a transition regionbetween the limiter distal portionand the limiter proximal portion. In certain embodiments, the angle X is about 30 degrees, about 35 degrees, about 40 degrees or other suitable angles. In some embodiments, the angle X is between about 30 degrees-40 degrees or about 33 degrees-37 degrees, or other suitable ranges of angles. In some embodiments, when the limiter distal portionassist spreading the tissue, the transition regionor a portion of the taper abuts a patient's scalpwhile the limiter distal portionabuts the skull. In other embodiments, the limiter distal portioncan be stepped down from the limiter proximal portionsuch that the transition regionis perpendicular with respect to the limiter distal portionand the limiter proximal portion. In this case, only the limiter distal portionabuts the craniumof a patient. In some examples, the limiter distal portionhas a diameter that is minimally larger than the drill bitallowing the limiter distal portionto extend within an incision. In other examples, the limiter distal portioncan be large and configured to extend around an incision.

106 170 106 170 170 172 172 170 172 156 170 170 172 172 156 172 156 172 172 170 172 170 172 172 172 a b In some examples, the depth limiteronly includes the adjustment collar. In certain other examples, the depth limiterincludes a locking nut configured to prevent rotation of the adjustment collarin a proximal direction. In some embodiments, the locking nut can be a nut that rotates up to the proximal end of the adjustment collar. In other examples, a ratchet mechanism or other suitable locking device can be used. In some embodiments the locking nut is a locking collar. The locking collaris configured to prevent the adjustment collarfrom rotating once a desired length of exposure of the bit distal is selected. In certain embodiments, the locking collaris attached to the sleeveand rotatable to abut against the adjustment collarthereby preventing the adjustment collarfrom moving proximally. In certain embodiments, the locking collarincludes internal threadsto rotatably attach to the sleevehowever, the locking collarcan attach to the sleevein any other method. For example, the locking collarcan include a ratchet mechanism or other suitable lock. In certain embodiments, the locking collarhas approximately the same width as the adjustment collar. In other embodiments, the locking collarcan have a smaller or greater width than the adjustment collar. The locking collaradditionally includes an exterior gripon at least a portion of the exterior thereby allowing the locking collarto be easily gripped and rotated by a user.

3 FIG. 100 200 200 202 206 208 210 200 212 208 210 212 depicts the surgical bone drillbeing used as a cranial drill to drill a hole in a craniumof a patient. The craniumincludes a scalp, a skull, a dura, and a brain. The craniumadditionally includes a subdural regionbetween the duraand the brain. As discussed above, in some cases a subdural hematoma can occur in the subdural regionwhich requires drainage.

202 108 121 202 108 202 202 170 202 108 4 FIG. b In operation, an incision can be made in the scalp, in some examples, the incision is relatively small and allows only for the drill bitto extend therethrough. In certain embodiments, the spikecreates the incision. In some examples, the scalpcan include tissue such as: skin, subcutaneous tissue, galea and periosteum. Depending on the size of the incision, only the drill bitextends through the incision and spreads the tissue of the scalp. In other examples, a tissue retractor (e.g., see) can be used to help spread tissue of the scalp. In some other examples, the limiter distal portionextends into the incision and assists with spreading the tissue of the scalp, without the use of a tissue retractor. In another example, the incision is small enough such that only the drill bitspreads the tissue. This allows for the incision to heal quickly and without the need of further medical assistance, for example, stitches.

108 206 108 104 130 123 108 104 108 126 206 120 208 212 170 200 170 202 206 170 202 3 FIG. b b b Once the incision is made, the drill bitcan be used to drill a hole through the skullby rotation of the drill bitvia the drive mechanism. As discussed above, the cutting portionincluding the cutting tipand flutes of the drill bitare responsible for the cutting work as the drive mechanismrotates the drill bit. A pre-selected length of the exposed bit distal portionis drilled through the skull. As can be seen in,, the distal endis sharp and pierces the durathereby allowing for the subdural regionto be drained. The limiter distal portionis configured to abut the cranium. In certain examples, the limiter distal portionassists with spreading the tissue of the scalpand abuts the skull. In other examples, the limiter distal portionis relatively larger and only abuts the scalp.

206 212 After a hole is drilled into the skull, a subdural drainage device, for example the drainage device shown in U.S. Pat. No. 7,694,821, can be used to drain the subdural region.

4 FIG. 300 300 100 306 302 304 300 400 108 400 108 300 206 208 206 400 Referring to, a surgical bone drillin a different embodiment is described. The surgical bone drillis similar to the surgical bone drilland includes a similar depth limiter, a similar housing, and a similar drive mechanism. However, the surgical bone drillincludes a drill bitthat is configured differently than the drill bit. The drill bit, similar to the drill bit, allows for enhanced grip of the surgical bone drillon the skullof a patient when in use and is similarly configured to pierce the duraof a patient (discussed in greater detail below) when drilled through the patient's skull. In some examples, the drill bitis configured as a cranial drill bit.

400 420 422 400 420 422 400 432 400 424 422 The drill bitcomprises a longitudinal body extending along an axis and having a distal endand a proximal endsuch that the drill bitextends between the distal endand the proximal end. The drill bitincludes spiral flute(s) formed around the body and extending from a cutting tipalong the axis of the body. The drill bitincludes a bit proximal portiontowards the proximal end.

400 426 420 426 430 130 432 400 434 432 420 434 420 121 434 434 434 The drill bitadditionally includes a bit distal portiontowards the distal end. The bit distal portionincludes a cutting portionsimilar to the cutting portionIn some examples, the cutting tipthat is a convex conical tip. The drill bitadditionally includes a spikethat extends from the cutting tipand terminates at the distal end. The spikecomes to a point as it reaches the distal endand functions similar to the spikediscussed above. In some examples the spikeis a conical spikethat comes to a sharp point. In some examples, the spikeincludes the cutting flute.

4 FIG. 3 FIG. 3 FIG. 4 FIG. 300 200 202 202 404 404 404 300 100 404 300 Referring again to, the surgical bone drillis being used as a cranial drill to drill a hole in a craniumof a patient (the cranium includes substantially the same parts as shown in). An incision has been made in the scalpand tissue of the scalpis being held open by a tissue retractor. In some examples, the tissue retractoris a “Holzheimer” retractor. In other examples, the tissue retractoris a “Mastoid” retractor, or a “Gelpi” retractor or a “Heiss” retractor. It will be appreciated that the surgical bone drillcan be used without the retractor in a similar method to that of. It will also be appreciated that the surgical bone drillcan be used with a tissue retractorsimilarly to the surgical bone drillof.

400 206 400 304 430 432 434 434 426 306 400 208 434 208 The drill bitcan drill a hole through the skullby rotation of the drill bitvia the drive mechanismthrough the cutting portionincluding the cutting tipand flutes. In examples where the spikeincludes the flutes, the spikecan also assist in the cutting work. Similarly, to the above example, a pre-selected length of the bit distal portionis selected, and the depth limiteris adjusted accordingly. As the drill bitreaches the dura, spikepierces the dura.

5 FIG. 500 510 512 510 512 100 300 500 525 525 526 526 525 510 Referring to, a kitincludes a surgical drillhaving a depth limiter. The drilland depth limiterare similar to the drills,discussed throughout. The kitstores the components in a container. The containermay include indentationswhich facilitate removal of the components stored within. The indentationsare optional and may or may not be included. The containermay be a suitable device for safe transportation of the drilland parts included.

510 514 510 510 The drillincludes a motorized drive mechanism (as discussed above). The kit further includes a charging mechanism. As depicted, the charging mechanism includes a charging cable, such as a USB C to USB A cable. The drillis depicted as being completely assembled with an exposed drill bit. It will be appreciated that in other examples, the drill may require assembly, the drill bit may be covered (as discussed above) or presented in a different suitable manner allowing for safe delivery of the drill.

500 510 500 520 520 In certain embodiments, the kitadditionally includes devices for use in conjunction with the drill, such as for draining a subdural hematoma. For example, the kitincludes a subdural evacuation port device. The subdural evacuation port devicecan be a suitable subdural evacuation port device, for example the subdural evacuation device shown in U.S. Pat. No. 7,694,821; the subdural evacuation device shown in co-pending U.S. application Ser. No. 18/347,474 entitled “Subdural Evacuation Port with Needle Access Port”; Ser. No. 18/347,515 entitled “Transparent Surgical Evacuation Port Device”; or 63/611,728 entitled “Surgical Evacuation Port Device with Sealing Device.” Each of which are incorporated herein by reference.

500 520 500 530 510 530 522 520 The kitadditionally includes devices useful for draining the subdural space in cooperation with the subdural evacuation port device. The kitincludes a tapwhich is configured to create threading within a hole that is created by the drill. Threads created by the tapcan, for example, facilitate connection with a skull engagement regionof the subdural evacuation port device. In other examples, any other devices useful in connection with the hole may be used, for example, other drainage devices, devices for extracting marrow from a bone, devices for providing nutrients to a bone or other suitable devices.

540 520 550 524 520 550 500 540 550 550 520 The kit may also include a conduitto, for example, connect the subdural evacuation port deviceto a negative pressure device. In some embodiments, the conduit connects to a fittingon the subdural evacuation port device. The negative pressure deviceis additionally included in the kitand can be any device capable of providing negative pressure through the conduit. As depicted, the negative pressure deviceis a bulb pump. The negative pressure devicemay also be an electrical pump, other manual pump such as a Hemovac or Blake drain. Further details related to the usage of the subdural evacuation port devicealong with more specific details of the subdural evacuation port device are disclosed in the patents referred to above.

In certain embodiments, the kit comprises instructional material. In certain embodiments, the instructional material includes a publication, a recording, a diagram, or any other medium of expression which can be used to communicate the usefulness of the device described herein. The instructional material of the kit of the disclosure, for example, can be affixed to a package which contains one or more instruments which may be necessary for the desired procedure. Alternatively, the instructional material is shipped separately from the package, or is accessible electronically via a communications network, such as the Internet.

In one embodiment, the disclosure includes a kit for portable use. To facilitate portable use, a kit of the present disclosure may further include a razor or clipper for removing hair from a subject, a ruler or tape measure for measuring the location of a site for incision, a surgical marker or other implement for marking the site of incision, skin preparation material (i.e., antiseptic, alcohol pads) to clean the site of incision, and any additional surgical and medical elements that may be useful for such an operation, such as surgical tape, gauze, bandages, surgical thread and needle, and the like.

Other advantages of the present invention can be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes, or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described in this document but is intended to include all changes and modifications that are within the scope and spirit of the invention as defined in the claims.

The term “approximately,” when used in connection with a numeric value, is intended to include values that are close to, but not exactly, the number. For example, in some embodiments, the term “approximately” may include values that are within +/−5 percent of the value.

This disclosure is not limited to the particular systems, methodologies or protocols described, as these may vary. The terminology used in this description is for the purpose of describing the particular versions or embodiments only and is not intended to limit the scope. It will be understood that terms such as “same,” “equal,” “planar,” or “coplanar,” as used herein when referring to orientation, layout, location, shapes, sizes, amounts, or other measures do not necessarily mean an exactly identical orientation, layout, location, shape, size, amount, or other measure, but are intended to encompass nearly identical orientation, layout, location, shapes, sizes, amounts, or other measures within acceptable variations that may occur, for example, due to manufacturing processes. The term “substantially” may be used herein to emphasize this meaning, unless the context or other statements clearly indicate otherwise. For example, items described as “substantially the same,” “substantially equal,” or “substantially planar,” may be exactly the same, equal, or planar, or may be the same, equal, or planar within acceptable variations that may occur, for example, due to manufacturing processes and/or tolerances. The term “substantially” may be used to encompass this meaning, especially when such variations do not materially alter functionality. As used herein, the term “proximal” means closest to the operator (less into the body) and “distal” means furthest from the operator (further into the body). In positioning a medical device from a downstream access point, distal is more upstream and proximal is more downstream. It will be understood that various modifications may be made to the embodiments disclosed herein. Likewise, the above disclosed methods may be performed according to an alternate sequence. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.